Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT07093567
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opiophobia in Adults With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barriers Questionnaire (BQ-13)', 'timeFrame': 'Through study completion; an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'To explore the barriers and fears related to use of opioids among a population of adult outpatients with advanced cancer who continue to experience pain after receiving a prescription for opioid analgesia and hypothesized associations among opiophobia, anxiety, depression, pain intensity, pain interference, and opioid medication adherence.', 'detailedDescription': 'Primary Objective:\n\nTo explore the barriers and fears related to use of opioids among a population of adult outpatients with advanced cancer who continue to experience pain after receiving a prescription for opioid analgesia.\n\nSecondary Objective:\n\nTo examine associations among opiophobia, anxiety, depression, pain intensity, pain interference, and opioid medication adherence among adults with advanced cancer who report undermanaged pain during the first week after receiving a prescription for an opioid analgesic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients with advanced cancer (defined as cancer that is unlikely to be cured and is locally advanced or distantly metastasized\n2. Pain is the documented reason for the Supportive Care consultation\n3. Have a prescription for an opioid analgesic\n4. Able to read, speak, and consent in English.\n\nExclusion Criteria:\n\n1. Age less than 18 years\n2. Do not have a prescription for an opioid analgesic\n3. Individuals for whom there is documentation of inability to provide consent in the medical record\n4. Women who are pregnant\n5. Patients with a substance use disorder (including alcohol use disorder and excluding tobacco use disorder) documented in the electronic health record under History of Present Illness or in the Medical History.'}, 'identificationModule': {'nctId': 'NCT07093567', 'briefTitle': 'Opiophobia in Adults With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Opiophobia in Adults With Advanced Cancer', 'orgStudyIdInfo': {'id': '2025-0177'}, 'secondaryIdInfos': [{'id': 'NCI-2025-05283', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eileen Hacker, PHD, RN', 'role': 'CONTACT', 'email': 'ehacker@mdanderson.org', 'phone': '713-563-4004'}, {'name': 'Eileen Hacker, PHD, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Eileen Hacker, PHD,RN', 'role': 'CONTACT', 'email': 'ehacker@mdanderson.org', 'phone': '(713) 563-4004'}], 'overallOfficials': [{'name': 'Eileen Hacker, PHD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}